MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 PCC PINK MCAN

Model Number	MMT-923600
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, it was reported that the patient was very ill, hard to breath, unsteady on the feet, feeling dizzy and experienced high blood glucose level (24.0 mmol/l).Therefore, the patient got insulin flow blocked alarm at 03:03 am, 07:04 am and 07:05 am, respectively.They tried to treat the high blood glucose level by changing the infusion set (last changed on (b)(6) 2021) and gave a bolus.The patient's site location was right side of the abdomen.Subsequently, on the day of this report ((b)(6) 2021), at 07:15 am, the patient was admitted to the hospital with blood glucose level of 24.0 mmol/l and was tested for ketone level (2.2 mmol/l).During hospitalization, the patient received insulin intravenously as corrective treatment.After spending three hours, the patient was still in the hospital at the time of this report and current blood glucose level was reported to be 10.6 mmol/l.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 PCC PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12947809
• Report Number: 3003442380-2021-00789
• Device Sequence Number: 20115631
• Product Code: FPA
• UDI-Device Identifier: 05705244007710
• UDI-Public: 05705244007710
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MMT-923600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/07/2021
• Patient Sequence Number: 1
• Patient Sex: Unknown